NA DH-221PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04931921115305), received between Aug 7, 2019 and Sep 19, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Output Problem” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019No Device Output; Output Problem; No Device Output; Output Problem

  IT WAS REPORTED THAT THE MULTIGAS UNIT (GF-210RA) FAILED DURING PATIENT USE. THE NUMERIC VALUES AND WAVEFORM WERE DROPPING OUT AND THE DEVICE WENT INTO A FLAT-LINE. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090464 ↗
• MalfunctionSep 5, 2019Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT GAVE AN "EXTERNAL MODULE FAILURE" ERROR MESSAGE DURING WARM UP AND IT DID NOT GO AWAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967771 ↗
• MalfunctionSep 4, 2019Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT IS INTERMITTENTLY GIVING AN "EXTERNAL DEVICE FAILURE" ERROR MESSAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8962364 ↗
• MalfunctionAug 16, 2019No Device Output; Sensing Intermittently; No Device Output; Sensing Intermittently

  IT WAS REPORTED THAT THE MULTIGAS UNIT INTERMITTENTLY DISPLAYED A "CHECK WATER TRAP" ERROR MESSAGE WHILE MONITORING THE PATIENT. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903837 ↗
• MalfunctionAug 15, 2019Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT WAS GIVING AN EXTERNAL GAS ERROR. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899791 ↗
• MalfunctionAug 9, 2019Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT WAS GIVING AN EXTERNAL GAS ERROR. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881113 ↗
• MalfunctionAug 9, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE CO2 AND SEVOFLURANE READINGS WEREN'T CORRECT ON THE MULTIGAS UNIT AND NO FURTHER INFORMATION WAS PROVIDED TO THEM BY THE STAFF. THE BIOMED BELIEVES THIS HAPPENED DURING A PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8881107 ↗
• MalfunctionAug 7, 2019Output Problem; Output Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE MULTIGAS UNIT WAS WORKING INTERMITTENTLY DURING A PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872044 ↗